HealthyPhase 1NCT03128606

A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG3067 in Healthy Subjects.

A Phase 1 study testing GLPG3067 single dose, GLPG3067 multiple dose and GLPG3067 oral suspension in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of… Read more about this study

Who is it for?: Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: GLPG3067 single dose, GLPG3067 multiple dose and GLPG3067 oral suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteBelgium
Study dates: 28 Mar 2017to 20 Feb 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female subject between 18-70 years of age, inclusive, on the date of signing the informed consent form (ICF).
Be of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]).
Have a body mass index between 18-30 kg/m2, inclusive.
Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead triplicate electrocardiogram (ECG), and clinical safety laboratory tests prior to the initial study drug administration.
Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal subjects) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration.

Who cannot join

Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
Clinically significant symptoms or illness in the 3 months before screening.
Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Any laboratory result considered by the investigator as clinically significant prior to study drug administration.
Creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula for subjects aged ≤50 years, or creatinine clearance ≤70 mL/min using the Cockcroft-Gault formula for subjects aged >50 years. A 24-hour urine collection to determine the actual value may be performed to confirm creatinine clearance if required.
Clinically significant abnormalities of vital signs at screening.
Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QT interval corrected for heart rate using Fridericia's formula [QTcF] >470 ms) or a known long QT syndrome. A first degree heart block or sinus arrhythmia will not be considered as a significant abnormality.
Participation in a drug, drug and device delivery system or combination, or biologic investigational research study within 8 weeks or 5 times the half-life of the investigational drug, if the half-life is known (whichever is longer) prior to initial study drug administration. Subjects who have been dosed previously with GLPG3067 in a clinical trial are allowed to participate Part 4 of this study as long as they completed their last follow-up visit or a washout period of 5 times the half-life of GLPG3067 (whichever is longer) after the last study drug administration is respected.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp

Other trials in Belgium

About this study

Official title: Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3067, the Combination of GLPG3067 and GLPG2222, and the Combination of GLPG3067, GLPG2222 and GLPG2737 in Healthy Female Subjects, Including a Relative Bioavailability and Food Effect Part for Single Dose of GLPG3067.

The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.

Conditions: Healthy
Being tested: GLPG3067 single dose, Placebo single dose, GLPG3067 multiple dose, Placebo multiple dose, GLPG3067 oral suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GLPG3067 single doseDrug
GLPG3067 oral suspension, single ascending doses, daily
Placebo single doseDrug
Placebo, oral suspension, daily
GLPG3067 multiple doseDrug
GLPG3067 oral suspension, multiple ascending doses, daily for 14 days
Placebo multiple doseDrug
Placebo, oral suspension, daily for 14 days
GLPG3067 oral suspensionDrug
GLPG3067 oral suspension, single dose, daily
GLPG3067 oral tabletDrug
GLPG3067 oral tablet, single dose, daily
GLPG3067/GLPG2222 multiple doseDrug
GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days
GLPG3067/GLPG2222 Placebo multiple doseDrug
GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days
GLPG3067/GLPG2222/GLPG2737 multiple doseDrug
GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days
GLPG3067/GLPG2222/GLPG2737 Placebo multiple doseDrug
GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days

Study groups in NCT03128606
Study group	Role	What they receive
GLPG3067 single dose	Experimental	Single dose of GLPG3067 oral suspension at up to 6 dose levels in ascending order. Receives: Drug: GLPG3067 single dose
Placebo single dose	Placebo comparator	Single dose of Placebo oral suspension. Receives: Drug: Placebo single dose
GLPG3067 oral suspension fed 1	Experimental	Single dose 1 of GLPG3067 oral suspension after a standardized breakfast. Receives: Drug: GLPG3067 oral suspension
GLPG3067 oral tablet fed 1	Experimental	Single dose 1 of GLPG3067 oral tablet after a standardized breakfast. Receives: Drug: GLPG3067 oral tablet
GLPG3067 oral tablet fasted 1	Experimental	Single dose 1 of GLPG3067 oral tablet after an overnight fast. Receives: Drug: GLPG3067 oral tablet
GLPG3067 oral tablet fed 2	Experimental	Single dose 2 of GLPG3067 oral tablet after a standardized breakfast. Receives: Drug: GLPG3067 oral tablet
GLPG3067 oral tablet fed 2 high-fat high-calorie	Experimental	Single dose 2 of GLPG3067 oral tablet after a high-fat high-calorie breakfast Receives: Drug: GLPG3067 oral tablet
GLPG3067 multiple dose	Experimental	Multiple doses of GLPG3067 oral suspension at up to 5 dose levels in ascending order. Receives: Drug: GLPG3067 multiple dose
Placebo multiple dose	Placebo comparator	Multiple doses of Placebo oral suspension. Receives: Drug: Placebo multiple dose
GLPG3067/GLPG2222 multiple dose	Experimental	Multiple doses of GLPG3067 oral suspension combined with GLPG2222 oral tablet up to 2 dose levels in ascending order. Receives: Drug: GLPG3067/GLPG2222 multiple dose
GLPG3067/GLPG2222 Placebo multiple dose	Placebo comparator	Multiple doses of GLPG3067 matching placebo oral suspension combined with GLPG2222 matching placebo oral tablet. Receives: Drug: GLPG3067/GLPG2222 Placebo multiple dose
GLPG3067/GLPG2222/GLPG2737 multiple dose	Experimental	Multiple doses of GLPG3067 oral tablet combined with GLPG2222 oral tablet and GLPG2737 oral capsule at up to 2 dose levels in ascending order. Receives: Drug: GLPG3067/GLPG2222/GLPG2737 multiple dose
GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose	Placebo comparator	Multiple doses of GLPG3067 matching placebo oral tablet combined with GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule. Receives: Drug: GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Change versus placebo in the proportion of subjects with adverse events
To assess safety and tolerability of single ascending doses, multiple ascending doses of GLPG3067 alone, or in combination with GLPG2222, or in combination with GLPG2222 and GLPG2737 versus placebo in healthy subjects
Measured: Between screening and 14 days after the last dose

Secondary outcomes (9)

Maximum observed plasma concentration of GLPG3067 (Cmax) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects
Measured: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects
Measured: Between Day 1 predose and 10 days after the last dose
Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects
To assess the potential for CYP3A4 interaction with GLPG3067, GLPG3067 and GLPG2222, or GLPG3067 and GLPG2222 and GLPG2737
Measured: Day 1 predose and Day 14
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fed state
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Measured: Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fed state
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Measured: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fed state
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Measured: Between Day 1 predose and 10 days after the last dose
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fasted state
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Measured: Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fasted state
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Measured: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fasted state
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Measured: Between Day 1 predose and 10 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 201720 Feb 2018

First posted25 Apr 2017
Study start28 Mar 2017
Primary completion20 Feb 2018
Study completion20 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03128606
Sponsor's protocol ID: GLPG3067-CL-101
Status last verified: Apr 2018
First submitted: 21 Apr 2017
Last updated: 10 Apr 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3067, the Combination of GLPG3067 and GLPG2222, and the Combination of GLPG3067, GLPG2222 and GLPG2737 in Healthy Female Subjects, Including a Relative Bioavailability and Food Effect Part for Single Dose of GLPG3067.
ClinicalTrials.gov ID: NCT03128606
Acronym / sponsor ID: GLPG3067-CL-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
Study start: 28 Mar 2017 (actual)
Primary completion: 20 Feb 2018 (actual)
Study completion: 20 Feb 2018 (actual)
First posted: 25 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 13

Arm	Type	Receives
GLPG3067 single dose	Experimental	Drug: GLPG3067 single doseSingle dose of GLPG3067 oral suspension at up to 6 dose levels in ascending order.
Placebo single dose	Placebo comparator	Drug: Placebo single doseSingle dose of Placebo oral suspension.
GLPG3067 oral suspension fed 1	Experimental	Drug: GLPG3067 oral suspensionSingle dose 1 of GLPG3067 oral suspension after a standardized breakfast.
GLPG3067 oral tablet fed 1	Experimental	Drug: GLPG3067 oral tabletSingle dose 1 of GLPG3067 oral tablet after a standardized breakfast.
GLPG3067 oral tablet fasted 1	Experimental	Drug: GLPG3067 oral tabletSingle dose 1 of GLPG3067 oral tablet after an overnight fast.
GLPG3067 oral tablet fed 2	Experimental	Drug: GLPG3067 oral tabletSingle dose 2 of GLPG3067 oral tablet after a standardized breakfast.
GLPG3067 oral tablet fed 2 high-fat high-calorie	Experimental	Drug: GLPG3067 oral tabletSingle dose 2 of GLPG3067 oral tablet after a high-fat high-calorie breakfast
GLPG3067 multiple dose	Experimental	Drug: GLPG3067 multiple doseMultiple doses of GLPG3067 oral suspension at up to 5 dose levels in ascending order.
Placebo multiple dose	Placebo comparator	Drug: Placebo multiple doseMultiple doses of Placebo oral suspension.
GLPG3067/GLPG2222 multiple dose	Experimental	Drug: GLPG3067/GLPG2222 multiple doseMultiple doses of GLPG3067 oral suspension combined with GLPG2222 oral tablet up to 2 dose levels in ascending order.
GLPG3067/GLPG2222 Placebo multiple dose	Placebo comparator	Drug: GLPG3067/GLPG2222 Placebo multiple doseMultiple doses of GLPG3067 matching placebo oral suspension combined with GLPG2222 matching placebo oral tablet.
GLPG3067/GLPG2222/GLPG2737 multiple dose	Experimental	Drug: GLPG3067/GLPG2222/GLPG2737 multiple doseMultiple doses of GLPG3067 oral tablet combined with GLPG2222 oral tablet and GLPG2737 oral capsule at up to 2 dose levels in ascending order.
GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose	Placebo comparator	Drug: GLPG3067/GLPG2222/GLPG2737 Placebo multiple doseMultiple doses of GLPG3067 matching placebo oral tablet combined with GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Female subject between 18-70 years of age, inclusive, on the date of signing the informed consent form (ICF).
Be of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]).
Have a body mass index between 18-30 kg/m2, inclusive.
Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead triplicate electrocardiogram (ECG), and clinical safety laboratory tests prior to the initial study drug administration.
Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal subjects) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration.

Key exclusion criteria (8 listed)

Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
Clinically significant symptoms or illness in the 3 months before screening.
Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Any laboratory result considered by the investigator as clinically significant prior to study drug administration.
Creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula for subjects aged ≤50 years, or creatinine clearance ≤70 mL/min using the Cockcroft-Gault formula for subjects aged >50 years. A 24-hour urine collection to determine the actual value may be performed to confirm creatinine clearance if required.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GLPG3067 single doseGLPG3067 oral suspension, single ascending doses, daily	Drug	GLPG3067 single dose
Placebo single dosePlacebo, oral suspension, daily	Drug	Placebo single dose
GLPG3067 multiple doseGLPG3067 oral suspension, multiple ascending doses, daily for 14 days	Drug	GLPG3067 multiple dose
Placebo multiple dosePlacebo, oral suspension, daily for 14 days	Drug	Placebo multiple dose
GLPG3067 oral suspensionGLPG3067 oral suspension, single dose, daily	Drug	GLPG3067 oral suspension fed 1
GLPG3067 oral tabletGLPG3067 oral tablet, single dose, daily	Drug	GLPG3067 oral tablet fasted 1, GLPG3067 oral tablet fed 1, GLPG3067 oral tablet fed 2, GLPG3067 oral tablet fed 2 high-fat high-calorie
GLPG3067/GLPG2222 multiple doseGLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days	Drug	GLPG3067/GLPG2222 multiple dose
GLPG3067/GLPG2222 Placebo multiple doseGLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days	Drug	GLPG3067/GLPG2222 Placebo multiple dose
GLPG3067/GLPG2222/GLPG2737 multiple doseGLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days	Drug	GLPG3067/GLPG2222/GLPG2737 multiple dose
GLPG3067/GLPG2222/GLPG2737 Placebo multiple doseGLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days	Drug	GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose

Primary outcome

Change versus placebo in the proportion of subjects with adverse events
Time frame: Between screening and 14 days after the last dose
To assess safety and tolerability of single ascending doses, multiple ascending doses of GLPG3067 alone, or in combination with GLPG2222, or in combination with GLPG2222 and GLPG2737 versus placebo in healthy subjects

9 secondary outcomes

Maximum observed plasma concentration of GLPG3067 (Cmax) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
Time frame: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
Time frame: Between Day 1 predose and 10 days after the last dose
Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects
Time frame: Day 1 predose and Day 14
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fed state
Time frame: Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fed state
Time frame: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fed state
Time frame: Between Day 1 predose and 10 days after the last dose
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fasted state
Time frame: Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fasted state
Time frame: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fasted state
Time frame: Between Day 1 predose and 10 days after the last dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Magdalena Petkova, MD study director

Lakefront Biotherapeutics NV

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLPG3067 single dose, GLPG3067 multiple dose and GLPG3067 oral suspension in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change versus placebo in the proportion of subjects with adverse events (time frame: Between screening and 14 days after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03128606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.